Electronic custody and control system for human assay test samples

ABSTRACT

A system, method, and computer program that may used to more quickly, accurately, and efficiently identify, catalog, and track human assay samples and create documentation with respect to the human assay samples. The computer program and method include the steps of: storing donor information in a donor information database accessible by a computer; storing client information in a client information database accessible by the computer; retrieving client information necessary to determine a type of test to be performed on a specimen; storing collection facility information in a collection facility database accessible by the computer; administering a human analyte test using the computer program to guide a collector of the specimen and identify problematic exceptions; receiving the test result electronically and storing the result in a test result database accessible by the computer; and permitting the client, Medical Review Officer, and other authorized persons to electronically access the test result via a communications network.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to human assay testing and trackingmethods. More particularly, the invention relates to a system, method,and computer program that may be used to more quickly, accurately, andefficiently catalog, test, and track human assay samples and createdocumentation with respect to the human assay samples.

2. Description of the Prior Art

Drug testing collection facilities spend a considerable amount of timeand money ordering, storing, filing, and indexing donors and clients andtracking the custody and control of specimens provided by donors. It isvery important that no mistakes are made in collecting and tracking drugtests, such as mislabeling a specimen with the incorrect donorinformation. Therefore, drug testing collection facilities incur greatexpense and time to ensure that the custody and control of specimens iswell-documented, correct, and forensically defensible.

Presently, most drug testing collection facilities manage specimencollection and tracking using mostly manual pen-and-paper methods. Sincea majority of drug tests are performed at the request of an employer orpotential employer of the donor, often for employment or pre-employmentscreening, a collection facility keeps a file of each employer'sinformation and the tests they desire to be performed. The collectionfacility personnel then retrieves the employer's file, looks up thetesting procedures the employer desires to be performed, and manuallynotes the selected information on a custody and control form (CCF).

Drug testing is often a regulated service, and thus, a CCF is required,or at least preferred, for each drug test a collection facilityadministers. A typical CCF will include the donor's name and other donorinformation, the employer's name and other employer information, thename of the collection facility and other collection facilityinformation, including the name of the collector collecting thespecimen, date and time of a specimen collection, and a uniqueidentifier identifying the specimen, such as a bar code. The CCF mayalso include the tests to be performed on the specimen, the results ofthe tests, and other identifying information. The CCF usually hasmultiple copies, often as many as seven, so that the donor, collectionfacility, employer, Medical Review Officer (MRO), and lab(s) may eachreceive a copy. Although most forms are a carbonless type, not allcopies contain the same information. For example, the donor's name andsignature is often blocked out of certain copies for confidentiality. Inmany cases, results may be reported to the MRO but not to the collector.This requires that each individual or business in the process is mailed,faxed, or somehow forwarded their respective copy of the CCF, often atconsiderable expense. Additionally, each individual or business mustthen file and store their respective copy of the CCF, incurringpersonnel expense and wasting valuable storage space.

A CCF is necessary to document and track a specimen collection process.The most important item the CCF includes is a unique identifier, whichidentifies the specimen. A collection facility cannot complete aspecimen collection until it has a unique identifier for the specimen.Therefore, the collection facility must have a CCF that contains aunique identifying label to be placed on the specimen and linking thespecimen to the donor identified on the CCF. In practice, the collectionfacility does not collect the specimen until the collection facility hasa CCF preprinted with the unique identifier, an employer's name, and aname of the MRO who will verify a positive lab result. Therefore, inorder for the collection facility to open an employer's account, thecollection facility commonly has CCFs for that employer preprinted withthe above information.

A lab commonly supplies CCFs to the collection facility, and it is thelab which preprints the CCFs with the unique identifying label, theemployer information, and the MRO's name. Once the lab preprints theCCFs, the lab then ships the forms to the collection facility oremployer, which must store the forms until used. Due to the timenecessary to request CCFs from the lab, wait for the lab to print eachCCF with its respective employer information, MRO name, and uniqueidentifier, and then ship the CCFs to the collection facility, it canoften take six weeks or more to open a new account and preprint CCFs foran employer, tens of thousands in some cases. During this time, none ofthe employer's employees can be tested using the preprinted CCFs.Consequently, the process of opening an account or changing accountinformation is unnecessarily time consuming and costly. Additionally, itis also common for each employer to have its own CCF, such that thecollection facility must order and maintain separate CCFs for eachemployer, thus furthering the cost and time of the testing process andcreating a burdensome storage problem for collectors. A change in formgraphics, MRO name, or client information results in destroyingthousands of unused forms. It is estimated that nearly fifty millionpaper CCFs, each two to seven parts, are used each year, while as manyas twenty-five million are destroyed, discarded, or never used.

A procedural example of administering a human assay test begins with thedonor producing a specimen, as is the case for a urine test. Thecollector must inspect the specimen for evidence of adulteration andnote any signs of adulteration on the CCF. The collector then determineswhether the specimen is within an acceptable temperature range and noteshis or her findings on the CCF. The specimen is sealed and the bar codelabel, which is attached to the CCF, is peeled away from the CCF andaffixed to the specimen container. The donor and collector sign the CCF,certifying that the information is correct, and the donor is dismissed.The collector then tests the specimen or prepares the specimen forshipment to a lab if the specimen is to be lab tested. Once received atthe lab, the specimen and CCF are inspected and the information manuallyrecorded on the CCF is manually entered by data entry personnel. Thedonor information, collector information, etc. are then transferred tothe Laboratory Information Management System (LIMS) so that a laboratoryreport contains all the appropriate CCF identifying information.

Receipt of test results and marrying results to CCFs are the mostproblematic and inefficient steps in the drug testing process and occurafter a results is reported. Turnaround time is often problematic and animportant consideration because employers typically desire to receivethe test results as soon as possible. A further problem of paper CCFs isthe storage, filing, and indexing of the CCFs, and the delays inremarrying the CCF copy to the lab results for record-keeping purposes.This results in delays in reporting the tests results while the CCF issearched and married to the results. An employer must then be notifiedof the results via phone, facsimile, mail, or even e-mail.

Another problem presented by having a paper CCF is remote specimencollection. For example, if an employer desires to administer a test ona potential employee residing in Dallas, but the employer's primaryplace of business is in Kansas City, and consequently, the location of acollection facility that administers tests for the employer, then theemployer must either transport the potential employee to Kansas City toproduce a specimen, or the collection facility must mail a CCF to acollection facility in Dallas, so that a test can be administered andreported to the proper authorized contact. This process istime-consuming and expensive and could be remedied with the presentinvention.

SUMMARY OF THE INVENTION

The present invention solves the above-described limitations andprovides a distinct advance in the art of identifying, cataloging, andtracking human analyte samples and creating documentation with respectto the human assay samples. Particularly, the invention provides asystem, method, and computer program that may be used to more quickly,accurately, and efficiently catalog donors and clients, test donors fordrugs, alcohol, and/or other substances or conditions, track specimensdiscarded and/or sent to a lab for further testing, and create anelectronic Custody and Control form (CCF) that documents a particularspecimen collection process. Furthermore, the CCF can be transmittedelectronically, and the computer program can search and marry the CCF tothe drug test results. Additionally, many aspects of the presentinvention may be used for identifying, cataloging, and tracking otheritems.

One aspect of the present invention includes a computer program andmethod operable to assist a collection facility in cataloging donors andclients and administering drug tests. The invention also assists the labby pre-accessing donor information and employer information such thatthe results can be quickly and efficiently linked to the original CCFdocumentation and assists a Medical Review Officer in evaluating andverifying lab results quickly and efficiently.

The method of administering a test broadly includes three steps: (1)collecting a specimen to be tested and creating a CCF for the specimen;(2) analyzing the specimen; and (3) medically reviewing and reportingthe test result to the client. Collecting a specimen and creating a CCFfor the specimen broadly includes the steps of: storing clientinformation in a client database accessible by the computer; storingdonor information in a donor database accessible by a computer; storingcollection facility information in a collection facility databaseaccessible by the computer; collecting a human analyte specimen from thedonor; identifying the specimen using a unique identifier; entering theunique identifier into the computer; storing the unique identifier in adatabase accessible by the computer; and creating a forensicallydefensible document, namely the CCF, which includes the donorinformation, the client information, the collection facilityinformation, the unique identifier, and other identifying information.

Analyzing a specimen broadly includes the steps of: aliquotting aportion of the specimen and applying the portion locally to ananalytical device that produces a test result; receiving the test resultelectronically from an instant testing device and storing the testresult in a test result database accessible by the computer; orpreparing the specimen for shipment to a lab to be tested, receiving thetest result electronically from the lab, and storing the test result ina test result database accessible by the computer.

Reviewing and reporting the test result broadly includes the steps of:determining whether the test result is positive or negative; permittingthe Medical Review Officer to verify the test result, if the test resultis positive, by accessing the test result via a communications network;and once verified, permitting a client or other authorized person toelectronically access the test result via the communications network.

In preferred forms, a client can access a test result and CCFdocumentation via the Internet, or other electronic means, quickly andwithout paper. For example, once the test result for a specimen isreported, either electronically from a lab or using a point of contacttesting device, the client, such as an employer, can access a testresult via the Internet. The client will not have to wait for theresult/CCF to be received from the collection site, for the marrying ofthe documents, nor for the documents to be sent via mail, facsimile,telephone, or otherwise. Additionally, a collection facility personnelwill not have to manually transmit each test result to the variouspeople or entities that desire the result.

Another aspect of the present invention includes a computer program andmethod for electronically creating a Custody and Control form (CCF) fortracking the specimen. Once the specimen is collected, the specimen islabeled with a unique identifier. The computer program of the presentinvention is then operable to create the CCF using the unique identifierof the specimen. Therefore, unlike the prior art, the collectionfacility can administer a test without using a preprinted paper CCF.

The CCF includes information such as the donor information, the clientinformation, the collection facility's information, the uniqueidentifier, as discussed above, and may include a reason for the test, aname of the Medical Review Officer (MRO), and a signature of both thedonor and a collector. The CCF serves as a reference source for thecollection facility and includes all information regarding theparticular specimen collector and donor. The CCF also documents thespecimen collection by requiring both the collector and donor'ssignature, which is especially important if the integrity of thespecimen collection is questioned. For example, if future questionsarise regarding the identity of the donor, the collection facility orMRO can refer to the CCF.

The CCF is electronically accessible by the collection facility, lab,MRO, and employer using a web-enabled or networked computer, and thecomputer program is operable to print the CCF locally, if needed. Anadvantage of the electronically-stored CCF is that the collectionfacility, lab, MRO, or employer do not have to manually file a paperCCF, thus reducing storage space and personnel time.

These and other important aspects of the present invention are describedmore fully in the detailed description below.

BRIEF DESCRIPTION OF THE DRAWING FIGURES

A preferred embodiment of the present invention is described in detailbelow with reference to the attached drawing figures, wherein:

FIG. 1 is a block diagram depicting an analyte testing device andseveral computer equipment components that may be used to implement oneor more preferred embodiments of the present invention;

FIG. 2 is a block diagram depicting the computer equipment of FIG. 1coupled with the computer equipment of others via a communicationsnetwork;

FIG. 3 is a flow diagram depicting the process of checking-in a donorusing a computer program and method of the present invention;

FIG. 4 is a flow diagram depicting the process of administering a testusing the computer program and method of the present invention;

FIG. 5 is a flow diagram depicting the process of a Medical ReviewOfficer (MRO) verifying a result using the computer program and methodof the present invention;

FIG. 6 is a plan view of an electronic Custody and Control form (CCF)that may be used to electronically document and verify a specimencollection process and to obtain information regarding the donor or thespecimen collection process.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention is preferably implemented with an analyte testingdevice 10 and a computer program that operates computer equipment,broadly referred to by the numeral 12 in FIG. 1. The present inventionis particularly configured for cataloging donors and clients, testingdonors for drugs and/or alcohol, tracking specimens tested at the pointof contact and/or sent to a lab for further testing, and creating aCustody and Control form (CCF) that documents a particular specimencollection process, but it may be used for other applications as well.

The analyte testing device 10 may be any device capable of receivingand/or testing human samples. The human sample may be urine, breath,blood, hair, saliva, sweat, etc. Examples of the analyte testing device10 are an instant urine testing device, including a cassette tape orintegrated into a specimen cup and lid, or a blood alcohol contenttesting device. The testing devices described herein are merely examplesof testing devices that may be used to implement the present inventionand may be replaced with other testing devices without departing fromthe scope of the present invention. Additionally, the computer programis operable to allow specimen testing by a lab.

In more detail, the specimen cup may be any device designed forreceiving and/or testing a human sample, such as a urine specimen cuporal fluid collection device, or blood tube. Preferably, the specimencup, in conjunction with the cup's lid, is capable of testing thetemperature of the specimen without having to insert a thermometer intothe specimen. Additionally, it is preferable that the specimen cup orlid be fitted with assaying indicia so that the urine can be instantlytested. It is also preferable, although not required, that a uniqueidentifier, such as a bar code, be attached to or printed on thespecimen cup or lid. One example of such a specimen cup and lid is soldby eScreen, Inc., of Overland Park, Kans., under the trade name eCup.

The automated urine testing device may be any instant testing devicedesigned to test a urine specimen quickly and on-site. One example ofsuch a testing device is sold by eScreen, Inc., of Overland Park, Kans.,under the trade name eReader.

The blood alcohol content testing device may be any instant devicedesigned to test blood or breath alcohol content quickly and on-site.One example of such a blood alcohol content testing device is sold byDraeger Safety, Inc., of Durango, Colo., under the trade nameBreathalyzer 7410.

Referring now to FIG. 1, the computer equipment 12 used to implement themethods of the present invention broadly includes a computer 13programmed as described herein, memory 14 accessible by the computer,and a printer 16. The computer equipment 12 may also include a handheldcomputing device containing a bar code scanner/reader 18 or a bar codescanner/reader 18 electronically connected to the computer 13 andcapable of transmitting information from a bar code to the computer 13and an electronic signature reader 20 connected to the computer 13 andcapable of transmitting an electronic signature to the computer 13. Thecomputer program and equipment 12 illustrated and described herein aremerely examples of a program and equipment that may be used to implementthe present invention and may be replaced with other software andcomputer equipment without departing from the scope of the presentinvention.

The computer 13 executes the computer program described herein and maybe operated by a collection facility or other entity which administershuman assay tests, such as an occupational health facility, an emergencyroom, a general care facility, a chiropractic office, a school, a court,or a police department. The computer 13 may be any computing device suchas a personal computer or network server. The computer 13 may beconnected to other computing devices, such as a firewall to preventtampering with information stored on or accessible by the computer 13.The computer 13 preferably includes conventional web hosting operatingsoftware, an Internet connection such as a modem, DSL converter, or ISDNconverter, and may be assigned a URL and corresponding domain name sothat it can communicate and be accessed via the Internet in aconventional manner.

The memory 14 is either resident in or accessible by the computer 13 andserves as a repository for data and programs used to implement certainaspects of the present invention as described in more detail below.

The computer 13 can preferably receive and transmit donor information,client information, and test results to and from clients, Medical ReviewOfficers (MROs), labs, and collection facilities. Therefore, thecomputer 13 is preferably capable of communicating with computingsystems 13,24,26,27, and 29 operated by these entities via acommunications network 22, as illustrated in FIG. 2. The communicationsnetwork 22 is preferably the Internet but may be any other conventionalcommunications network such as a local area network, a wide areanetwork, a wireless network, or an intranet.

The computer program of the present invention is stored in or oncomputer-readable medium residing on or accessible by the computer 13such as the memory 14. The computer program preferably comprises anordered listing of executable instructions for implementing logicalfunctions in the computer 13 or the equipment coupled with the computer13. The computer program can be embodied in any computer-readable mediumfor use by or in connection with an instruction execution system,apparatus, or device, such as a computer-based system,processor-containing system, or other system that can retrieve theinstructions from the instruction execution system, apparatus, ordevice, and execute the instructions. In the context of thisapplication, a “computer-readable medium” can be any means that cancontain, store, communicate, propagate or transport the program for useby or in connection with the instruction execution system, apparatus, ordevice. The computer-readable medium can be, for example, but notlimited to, an electronic, magnetic, optical, electro-magnetic,infrared, or semi-conductor system, apparatus, device or propagationmedium. More specific, although not inclusive, examples of thecomputer-readable medium would include the following: an electricalconnection having one or more wires, a portable computer diskette, arandom access memory (RAM), a read-only memory (ROM), an erasable,programmable, read-only memory (EPROM or Flash memory), an opticalfiber, and a portable compact disk read-only memory (CDROM). Thecomputer-readable medium could even be paper or another suitable mediumupon which the program is printed, as the program can be electronicallycaptured, via for instance, optical scanning of the paper or othermedium, then compiled, interpreted, or otherwise processed in a suitablemanner, if necessary, and then stored in a computer memory.

The printer 16 is coupled with the computer 13 and is provided forprinting forms, certificates, or reports as described in more detailbelow. The printer 16 may be any conventional printer, such as a laserprinter or ink jet printer.

The handheld computing device may be any device that contains a bar codescanner/reader 18. If preferred, the bar code scanner/reader 18 iselectronically attached to the computer 13 and capable of transmitting abar code to the computer 13.

The electronic signature reader 20 may be any device that is capable ofreceiving a handwritten signature electronically and transmitting theelectronic signature to the computer 13.

In accordance with one aspect of the invention, the computer equipment12 and analyte testing device 10 described above are used to assist acollection facility in cataloging donors and clients, testing donors'specimens for drugs and/or alcohol, tracking specimens discarded and/orsent to a lab for further testing, and creating a Custody and Controlform (CCF) that documents a particular specimen collection process. Tocatalog clients, a collection facility stores client information in aclient database residing on the memory 14. Preferably, clientinformation includes the client's name, billing and shippinginformation, office contact, and other identifiers. Once populated, theclient database contains information for all clients using thecollection facility's services.

The method of administering a test broadly includes three steps: (1)collecting a specimen to be tested and creating a CCF for the specimen;(2) analyzing the specimen; and (3) medically reviewing and reportingthe test result to the client. Collecting a specimen and creating a CCFfor the specimen broadly includes the steps of: storing donorinformation in a donor database accessible by a computer; storing clientinformation in a client database accessible by the computer; storingcollection facility information in a collection facility databaseaccessible by the computer; retrieving client information necessary todetermine a type of test to be performed on the specimen; selecting areason for taking the test; administering a test using the computerprogram to guide a collector and identify problematic exceptions;labeling the specimen produced by the donor with a unique identifier,such as a bar code; storing the unique identifier identifying thespecimen in a unique identifier database accessible by the computer; andcreating a forensically defensible CCF which includes the donorinformation, the client information, the collection facilityinformation, the unique identifier, and other identifying information.

Analyzing a specimen broadly includes the steps of: aliquotting aportion of the specimen and applying the portion locally to ananalytical device that produces a test result; receiving the test resultelectronically from an instanttesting device and storing the test resultin a test result database accessible by the computer; or preparing thespecimen for shipment to a lab to be tested, receiving the test resultelectronically from the lab, and storing the test result in a testresult database accessible by the computer.

Reviewing and reporting the test result broadly includes the steps of:determining whether the test result is positive or negative; permittinga Medical Review Officer to verify the test result, if the test resultis positive, by accessing the test result via a communications network;and permitting a client or other authorized person to electronicallyaccess the test result via the communications network.

These and other steps are described in more detail below.

Collecting a Specimen to be Tested and Creating a CCF for the Specimen

Before beginning the process of administering a test, a client accountmust be opened. To open a client account, client information is enteredinto a computer and stored in a client database residing on thecomputer's memory. Client information includes the name and address ofthe client and the type(s) of test(s) the client desires to be performedon a specimen.

To begin the process of testing a donor's specimen and tracking thedonor's test results, a user, such as an employee of the collectionfacility, must first check-in the donor, the process of which isdepicted in FIG. 3. The computer program is operable so that the userwho checks-in the donor may be different than the collection facilitypersonnel who collects the specimen from the donor. To check-in a donor,a user first selects the donor's employer from the client database, asdepicted in box 3A. If the donor is a private client or is not anemployee or a potential employee of an employer or previously contractedemployer, then the user has the option of selecting the collectionfacility's house account as the employer or open a new account.

After selecting the donor's employer, the user enters donor informationinto the computer 13, as depicted in box 3B. The computer 13 stores thedonor information in a donor database residing on the memory 14. Oncepopulated, the donor database contains information for all donorsadmitted to be tested. The donor information preferably includes thedonor's first and last name, the donor's birthday, the donor's socialsecurity number, and the donor's daytime and evening phone number.However, donor information sufficient to track the donor, such as socialsecurity number, is acceptable. Additionally, another embodiment of thecomputer program allows a client to enter the donor's informationinstead of the collection facility entering the donor's information.

Once the donor information has been entered, the computer programprompts the user to select the type of test(s) to be performed on thespecimen, as depicted in box 3C. The computer program may be used tocatalog and track donors and to catalog clients for both lab-evaluatedtests and instant testing devices. Additionally, the computer programmay be used with a variety of instant testing devices. In oneembodiment, the user may choose either a Department of Transportation(DOT) test or a non-Department of Transportation (non-DOT) test. Sincethe DOT requires that all tests be lab-evaluated, as opposed to usinginstant testing devices, the computer program is designed so that theuser must choose a lab-evaluated test for DOT tests. If the test to begiven is a non-DOT test, then the user may choose either a lab test oran instant test. For both DOT and non-DOT tests, if the user desires toperform multiple tests on a specimen, the computer program is designedto allow the user the option of choosing more than one test to beperformed. Additionally, since the user previously entered the donor'semployer, if applicable, then the test(s) the employer desires to beperformed are already selected, thus eliminating the need for the donoror user to determine which test(s) an employer wants performed.

After selecting the type of test, the computer program prompts the userto select the reason for the test, as depicted in box 3D. Possiblereasons for taking a urine or breath test include pre-employmentscreening, post-accident, return to duty, reasonable suspicion/cause,random, etc. Once the reason for the test is selected, the donorcheck-in process is complete and a collector may administer a test.

The computer program is designed with several security procedures toprevent tampering of data stored on the memory 14. One such procedurerequires the collector to enter his or her name and password beforecollecting a specimen from the donor, as depicted in box 4A. Aspreviously noted, the collector of the specimen may be a differentcollection facility personnel than the user who checked-in the donor. Anadditional security procedure requires that the collector who beginsadministering a test with respect to a particular donor is also the samecollector who finishes administering the test with respect to theparticular donor. Therefore, the computer program is designed so thatmultiple collectors do not have access to the donor's information andtesting status while a test is being performed. This proceduralrequirement protects the integrity of the system and ensures that donorinformation and testing results are not manipulated by human error orunauthorized personnel.

In addition to the above security procedures, the computer programstores a list of collection facility personnel using the computerprogram, along with each personnel's privileges, in a personnel databaseresiding on the memory. Since a collector of a specimen must enter apassword before beginning collection of the specimen, the computerprogram restricts the collector to administration of only those teststhe collector is privileged to administer. For example, an evidentialbreath testing (EBT) device often requires training and certification touse. The computer program is operable to allow only those collectors whohave the necessary certification to administer an EBT.

After at least one donor is checked-in, as described above, a collectionfacility personnel may begin administering a test, the process of whichis depicted in FIG. 4. The collector must first log onto the computerprogram, as depicted in box 4A. Next, the collector must verify thedonor's information, as depicted in box 4B, by cross-referencing thedonor's information with preferably the donor's Driver's License,Identification Card, passport, or other identifier and the donor'sSocial Security Card. As previously noted, the computer program isoperable to test and track urine, breath, blood, hair, saliva, sweat,etc. To administer a urine test, the collector gives the donor a cup andrequests the donor to provide a specimen, as depicted in box 4C. Oncethe donor has provided a sufficient specimen, the collector inspects thespecimen for signs or indications of adulteration, such as unusual odor,unusual color, etc., as depicted in box 4D. The computer program promptsthe collector to indicate any signs or indications of adulteration. Ifthe specimen does have signs or indications of adulteration, thecomputer program is operable to manage exceptions or deviations from theroutine, as detailed below.

Next, the computer program prompts the collector to indicate whether thespecimen is within an acceptable temperature range, which isapproximately 90°-100° F. (32°-38° C.), as depicted in box 4E. Mosturine testing devices have a temperature strip, which is easilyreadable, placed directly on the cup. If the specimen's temperature isnot within the acceptable range, the computer program prompts thecollector to withdraw a portion of the specimen and test the temperatureof the withdrawn portion using a thermometer. The computer program thenasks the collector one or more questions to determine whether thetemperature of the specimen is within the acceptable range. If thespecimen is not within the acceptable temperature range, the computerprogram is operable to manage exceptions or deviations from the routine,as detailed below.

After the collector inspects the specimen for signs of adulteration andnotes the temperature range of the specimen, the collector seals thespecimen, as depicted in box 4F. The computer program catalogs andtracks the specimen using a unique identifier, such as a bar code. If abar code is already present on the specimen cup or lid, the collectorscans the bar code using a bar code scanner/reader 18, as depicted inbox 4G. The bar code is then electronically transmitted to a uniqueidentifier database residing on the memory 14. If the collector does nothave a bar code scanner/reader 18, the collector must manually enter thebar code into the unique identifier database. If the specimen cup or liddoes not have a bar code on it, the collector has the option of placinga bar code on the specimen cup or lid and entering the bar code into theunique identifier database as described above. After the bar code isentered into the unique identifier database, either using a bar codescanner/reader 18 or manually entering the bar code, the collector isrequested to validate the bar code, as depicted in box 4H. This is asecurity measure of the computer program designed to ensure that nospecimen with that unique identifier has been previously tested. Thecomputer program accesses the unique identifier database stored on thememory 14 and cross-references the present specimen's unique identifierwith all other unique identifiers in the unique identifier database.

After the specimen is validated, the donor is requested to sign and datean electronic Custody and Control form (CCF), as depicted in box 4I. TheCCF, broadly referred to by the numeral 60 in FIG. 6, is used as areference source for the collection facility or a lab and includesinformation regarding the specimen collection and donor. For example,the CCF 60 indicates whether the specimen was within an acceptabletemperature range 70. Additionally, the CCF 60 is documentation andverification of the specimen collection process. For example, thedonor's signature 80 on the CCF 60 evidences the donor's confirmationthat the specimen collection is as documented on the CCF 60.

A CCF 60 preferably contains the following: the unique identifier 62identifying the specimen, such as a bar code; a lab identificationnumber and account number 64, if applicable; information regarding theclient 66, such as the client's name, address and contact person; theMedical Review Officer's name 68; an indication of whether the specimenwas within an acceptable temperature range 70; an indication that thedonor's identification was verified 72; information regarding the typeof specimen 74, such as urine, oral, blood, or breath; the reason fortaking the test 76; information regarding the donor 78, such as thedonor's name, social security number, date of birth, and daytime andevening phone number(s); the donor's signature 80; the collectionfacility's name and address 82; the name of the collector collecting thespecimen 84; the signature of the collector 86; a lab personnel'ssignature 88, if applicable; an indication whether the test result isnegative 90; and the MRO's signature 92.

An advantage of the present invention is that a preprinted paper CCF isnot needed to administer a test. Unlike the prior art, the computerprogram is operable to electronically create a CCF 60 using the uniqueidentifier for the specimen. Additionally, all reference information andidentifying information for the specimen collection process can beelectronically accessed to quickly complete the electronic CCF 60. Inorder to complete the CCF, the computer program is operable toelectronically access the donor information database, the clientinformation database, the collection facility database, the uniqueidentifier database, the test result database, as detailed below, andthe Medical Review Officer database, as detailed below. The computerprogram then automatically completes the CCF 60 using the informationaccessed from each of the above-listed databases and stores the CCF 60in a CCF database residing on the memory 14. Therefore, the collectordoes not have to manually complete the CCF 60. The computer program isoperable to generate any CCF 60 from the CAC database bycross-referencing a donor's name, a donor's social security number, or aunique identifier on a completed CCF 60 with the donor informationdatabase or the unique identifier database. Additionally, the computerprogram is operable to print the CCF 60 if desired. For example, a CCF60 must accompany any test sent to a lab to be tested, and thus, aprinted CCF 60 is required.

The CCF 60 may be signed by the collector and donor electronically usingan electronic signature reader 20. The computer program is operable toreceive an electronic signature from the electronic signature reader 20and store the electronic signature as part of the CCF 60 in the CCFdatabase. If the CCF 60 is signed using an electronic signature, thereis no need to print the CCF 60, unless the donor requests a copy. If thecollection facility does not have an electronic signature reader 20, thecollector has the option of printing the CCF 60 for the donor andcollector's signature.

Analyzing the Specimen

Once the CCF 60 is signed and dated, the collector signs and dates thespecimen in the presence of the donor, as depicted in box 4I, and thedonor is dismissed. At this time, the collector tests the specimen usingthe analyte testing device 10 or prepares the specimen for shipment to alab if the specimen is to be lab tested. Once the instant testing iscomplete, the collector enters the test result in the computer program,which stores the test result in a test result database residing on thememory 14. If the analyte testing device 10 is electronically connectedto the computer 13, the computer program is operable to electronicallyreceive the test result from the analyte testing device 10 and store thetest result in the test result database. The computer program is alsooperable to allow a collector to perform an instant test and manuallyenter the test result into the test result database at a later time. Ifthe test result is negative, the collector discards the specimen. If thetest result is non-negative, the collector prepares the specimen forshipment to the lab. For a non-negative test result, it is preferablethat the CCF 60 accompanies the specimen for shipment to the lab.Additionally, the computer program is operable to receive the testresult from the lab electronically via the communications network 22 andto store the received test result in the test result database.

The process to administer a breath test is similar to theabove-described process for administering a urine test. The primarydifference between a urine test and a breath test is that for a breathtest, there is no specimen for the collector to collect and handle. Thecollector must merely enter the result of the breath test into thecomputer program, which stores the test result on the test resultdatabase residing on the memory 14. The computer program then indicateswhether the results are within an acceptable range.

The computer program is designed to accommodate exceptions or deviationsfrom the above process. Possible deviations or exceptions, although notinclusive, are the following: donor has no valid identification; donorrefuses to take the test; donor cannot produce a specimen or donorcannot breathe into the blood alcohol content testing device; donor doesnot produce enough urine to test; specimen appears adulterated; orspecimen's temperature is not within the acceptable range. The computerprogram is also operable to accommodate a client's desire on how tomanage exceptions or deviations from the above process. For example, ifa donor's specimen is not within the acceptable temperature range, theclient can design its computer program so that the collection facilityhas instructions to send the specimen to the lab.

Reviewing and Reporting the Result

The computer program is also operable to allow Medical Review Officers(MROs) access to lab results via the communications network 22. In apreferable embodiment, many collection facilities or employers willchoose to have a medical doctor review and verify positive lab results,the process of which is depicted in FIG. 5. The MRO who reviews the labresults is listed on all CCFs for which the collection facility collectsa specimen, regardless of whether the test performed is instantly testedor lab tested.

Once a test result is entered into the test result database residing onthe memory 14, the MRO can access, review, and verify the test resultelectronically via the communications network 22. To verify a testresult, the MRO selects the MRO button displayed by the computerprogram. The computer program then prompts the MRO to enter his or hername and password, as depicted in box 5A. Once logged onto the computerprogram, the computer program displays a list of the lab resultsawaiting verification by the MRO. The MRO may then choose which labresult to verify, as depicted in box 5B. The computer program alsoprovides the MRO with an auto-verify option that automatically verifiesnegative lab results. Preferably, the MRO next checks that the donor andspecimen information is complete and correct for the result the MRO isverifying, as depicted in box 5C. The MRO will then be requested toreview the analytes for which the specimen was tested, as depicted inbox 5D.

For a test result the lab marks positive, the MRO can edit quantitiesand enter comments and a final determination, as depicted in box 5E.Therefore, the computer program allows the MRO the option of overturningor canceling a positive lab result. The computer program does not allowthe MRO to overturn a negative lab result. If the lab detects anadulterant in a specimen, the computer program marks the test result asadulterated. Any adulterants the lab identifies are listed below theregular analytes.

Once the MRO completes verification of a specimen, the computer programgives the MRO the option of re-sending the test result to the client, asdepicted in box 5F. Additionally, the computer program has the option ofre-verifying a specimen, which is similar to the verification processdescribed above.

The computer program is also operable to compile and print variousreports, forms, and certificates upon request. The possible reports,forms, or certificates, although not inclusive, are the following:Collection Average Wait Time report; Turnaround Time report; SpecimenResults certificate; DOT Statistics report; Client Account Summaryreport; Test Activity report; Client List; Collections by Collectorreport; Shipping report; Custody and Control form; and Client Setupform. The Collection Average Wait Time report shows clients how long, onaverage, their employees were waiting to be tested from the time theemployee checked-in to the moment the collection was complete. TheTurnaround Time report shows clients how long the testing cycle takesfrom the time their donor checked-in at the collection facility to thetime the client received the test results. The Specimen ResultsCertificate shows clients the official determination of a specimen. TheDOT Statistics report allows a collection facility's clients to showthat they are performing adequate drug tests on their employees to stayin compliance with Department of Transportation guidelines. The ClientAccount Summary report provides a collection facility with a summary ofa client's account. The Test Activity report allows a collectionfacility to view and print all tests administered by the collectionfacility in a given date range. A Client List lists all clients andtheir information. A Collections by Collector report is a list of allthe tests a collector administered over a given time and/or date range.A Shipping Reporttells a collection facility which specimens need to besent to which labs. The Client Setup form is for collection facilitysales personnel to fill out and give to the personnel who enter newclients into the client database.

As previously noted, the computer program is operable to be connected toother computers via a communications network 22. Therefore, the computerprogram can share information with other providers 28, both on a localand national level, and the computer program can share information witha collection facility's clients 26. In addition, the computer program'sadministrator 30 can monitor all collection facilities' use and testresults. In a preferable embodiment, the computer program is connectedto the Internet to allow a client to electronically access a collectionfacility's reports regarding the test results of the client's employeesor potential employees. For example, a client would be able to access aSpecimen Results Certificate to obtain the official determination of adonor's test result. The computer program is also operable to exchangeinformation via facsimile using a telephone system or via an automatedvoice response using a telephone system.

Although the invention has been described with reference to thepreferred embodiment illustrated in the attached drawing figures, it isnoted that equivalents may be employed and substitutions made hereinwithout departing from the scope of the invention as recited in theclaims.

Having thus described the preferred embodiment of the invention, what isclaimed as new and desired to be protected by Letters Patent includesthe following:
 1. A system for assisting an entity in tracking thecustody and control of a human analyte specimen provided by a donor,wherein the specimen is stored in a container assigned with a uniqueidentifier, the system comprising: an electronic testing device fortesting the human analyte specimen provided by the donor; an electronicsignature reader for receiving a handwritten signature from the donorand converting the handwritten signature to a digital form; and one ormore processors associated with one or more computers, the one or moreprocessors configured for executing a computer program operable toperform the steps of: receive, from an employer, information identifyingthe donor, wherein the employer is requesting that a test be performedon the human analyte specimen provided by the donor, and the donor iseither an employee or a candidate for employment with the employer;store the information identifying the donor in a donor database;receive, from an employer, information identifying the employer and atleast one test requested by the employer to be performed on thespecimen; store the information identifying the employer and the atleast one test in an employer database; enable a collector associatedwith a collection facility to access the information identifying thedonor from the donor database and the information identifying theemployer and the at least one test requested by the employer from theemployer database; receive information identifying the unique identifierassigned with the specimen container, wherein the informationidentifying the unique identifier is initially received by the programvia scanning the unique identifier assigned with the specimen containeror inputting the unique identifier assigned with the specimen containerinto the program; subsequent to receiving the information identifyingthe unique identifier assigned with the specimen container, associatinga computer-generated, forensically-defensible Custody and Control Form(CCF) that identifies the donor with the unique identifier assigned withthe specimen container, such that the CCF is identified, for a firsttime, with the unique identifier assigned with the specimen container;wherein said associating the CCF using the unique identifier assignedwith the specimen container occurs subsequent to said receiving theinformation identifying the unique identifier assigned with the specimencontainer, wherein the CCF is electronically available to the entity viaan application accessible via a communications network; populate the CCFwith the at least some of the information identifying the donor, whereinsaid step of populating the CCF includes importing the at least some ofthe information identifying the donor from the donor database;